A Sardine Diet Intervention Study to Assess Benefits to the Metabolic Profile in Type 2 Diabetes Mellitus Patients

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Sardine diet

• Registration Number: NCT02294526
• Lead Sponsor: Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

Brief Summary

Work hypothesis

A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2014-10-31
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-16
• Study First Posted: 2014-11-19
• Last Update Submitted: 2015-01-28
• Last Update Posted: 2015-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Age > 40 years and < 85
• BMI ≥ 25 and < 35
• Patients diagnosed with type 2 diabetes at onset or treated only by diet
• HbA1c between 6.0 and 8.0% (based on the last measured and documented laboratory measurement of the previous 3 months)
• Usual consumption ≤ 3 fish per week

Exclusion Criteria

• T2D treated with antidiabetic oral drugs and/or insulin
• Current or previous (within 3 months) intake of omega 3 suplements
• Known allergy or intolerance to fish or fish protein
• Diagnosis of active neoplasic disease
• Suffering from an acute illness which requires a recovery period higher than one week
• Currently chronic treatment with oral steroids or nonesteroidal anti-inflammatory for more than 5 days, at least 1 month before randomization
• Pregnant or breast-feeding patients
• Serious acute vascular events (cardiac or cerebral) diagnosed previous 2 months before the randomization
• Current or previous (within 6 months) participation in another study
• Chronic renal insufficiency (creatinine >1,5 mg/dl)
• Any conditions that the investigator considers may render the patient unable to complete the study

During the interventional study, based on current standards of T2D care, doctors will introduce anti-diabetic oral drugs or insulin into the patient's treatment, where they consider it to be necessary.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sardine diet	Sardine diet	Subjects follow general dietary recommendations for diabetes including a fixed amount of sardine in daily meals (100g per day, 5 days a week) as part of their usual diet.

Primary Outcome Measures

Name	Time	Method
Change from baseline in fasting glucose at 6 months	Baseline and 6 months
Change from baseline in glycated hemoglobin (HbA1c) at 6 months	Baseline and 6 months
Change from baseline in fasting insulin at 6 months	Baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in HDL cholesterol at 6 months	Baseline and 6 months
Change from baseline in blood pressure at 6 months	Baseline and 6 months
Change from baseline in tumor necrosis factor alpha (TNFα) at 6 months	Baseline and 6 months
Change from baseline in specific bacterial groups of gut microbiota at 6 months	Baseline and 6 months
Change from baseline in leptin at 6 months	Baseline and 6 months
Change from baseline in LDL cholesterol at 6 months	Baseline and 6 months
Change from baseline in adiponectin at 6 months	Baseline and 6 months
Change from baseline in ultra sensitive C-reactive protein (us-CRP) at 6 months	Baseline and 6 months
Change from baseline in interleukin-6 (IL-6) at 6 months	Baseline and 6 months
Change from baseline in interleukin-8 (IL-8) at 6 months	Baseline and 6 months
Change from baseline in interleukin-10 (IL-10) at 6 months	Baseline and 6 months
Change from baseline in erytrocite membrane fatty acid composition (EMFA) at 6 months	Baseline and 6 months
Change from baseline in total cholesterol at 6 months	Baseline and 6 months
Change from baseline in triglycerides at 6 months	Baseline and 6 months